Kornimate/medical-research-clean huggingface dataset:
in vivo kinematics for subjects with smith & nephew journey ii bcs tka, journey ii cr tka, or journey ii xr tka

Conditions: Knee Osteoarthritis; Total Knee Arthroplasty; Knee

Summary: the objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (vag) signals for subjects implanted with journey ii bi-cruciate stabilized (bcs), cr (cruciate retaining), and bi-cruciate retaining (xr) tkas.

the objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (vag) signals for subjects implanted with journey ii bi-cruciate stabilized (bcs), cr (cruciate retaining), and bi-cruciate retaining (xr) tkas. the journey ii bcs knee system was designed to resect and replicate both the pcl and acl, the journey ii cr system retains the posterior cruciate ligament, while the journey ii xr system retains the cruciate and collateral ligaments so they remain intact.

Eligibility criteria:
inclusion criteria: 1. patients in the age range of 18 years to 85 years (both inclusive) 2. patients who have a bmi less than 35 3. patients who do not have previous surgery on the implanted knee that might restrict their movement 4. patient who are at least 6 months post-operative 5. patients who do not experience any pain or other post-operative complications 6. patients who have a stable tka and can perform a deep knee bend activity 7. patients who are willing to participate in this study and are willing to sign appropriate hipaa and informed consent forms 8. subjects will have a journey ii, either the bcs or xr, knee system exclusion criteria: 1. pregnant, potentially pregnant, or lactating females. to satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. a pregnant person will not be allowed to participate in the study. 2. patients who have currently enrolled in a fluoroscopic study within the past year. 3. patients currently involved in any personal injury litigation, medical/legal or workman's compensation claims. 4. patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study. 5. patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability 6. subjects who are unable to perform a deep knee bend. 7. subjects who are unwilling to sign informed consent/ hipaa documents. 8. subjects without the required type of knee implant.

Keywords: total knee arthroplasty
a pharmacokinetic study comparing the liraglutide injection (rd12014) and victoza® in healthy chinese subjects

Conditions: Type 2 Diabetes

Summary: to evaluate the pharmacokinetics similarity between the liraglutide injection (rd12014) produced by sunshine lake pharma co., ltd. and liraglutide injection (victoza®) produced by novo nordisk pharmaceutical co., ltd for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between rd12014 and victoza ® in healthy subjects.


Eligibility criteria:
inclusion criteria: * 1. being willing to participate in the experiment, fully understand and sign the informed consent, fully understand and able to complete the experiment according to the requirements of the experiment protocol; * 2. aged between 18 and 45 years old of healthy male subjects ; * 3. weight ≥50kg, and body mass index(bmi)= 19.0-26.0 kg/m2 ; * 4. no history of respiratory system, cardiovascular system, digestive system, urinary system, hematological system, endocrine system,nervous system or metabolic abnormalities; * 5. normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, abdominal ultrasound examination and chest x-ray examination have no clinical significance; exclusion criteria: * 1. have a history of fainting needles, fainting blood; * 2. positive for hepatitis (including hepatitis b and c), hiv or syphilis at screening; * 3. have taken any prescription, over-the-counter, herbal medicine or health care products (other than normal vitamin products)within 2 weeks prior to the use of the study drug; * 4. have a history of taken liraglutide or other human glucagon-like peptides-1 analogues before the trial; * 5. those who have been screened positive for drugs at screening; * 6. donated blood (\> 400 ml) within 3 months before taking the study drug; * 7. heavy smoker or those who smoked more than 10 cigarettes per day before taking the study drug. * 8. alcohol abuse (drinking 21 units of alcohol per week: 1 unit = 360 ml of beer or 45 ml of 40% alcoholic spirits or 150 ml of wine) or positive for breath alcohol test ; * 9. those who have been screened positive for drugs or have a history of drug abuse; * 10. known allergy to liraglutide or any of the excipients of the formulation; * 11. those who have a history or family history of medullary thyroid cancer (grandparents, parents and siblings), or inherited diseases that predispose them to medullary thyroid cancer;or have a history or family history of multiple endocrine adenomatosis; * 12. have participated in the drug clinical trial and taken the test drug within 3 months before taking the study drug; * 13. during the trial period and within 3 months after the last dose, those who want their female partners to become pregnant or is unwilling to use reliable contraceptive methods * 14. other cases judged by researchers to be unsuitable for selection.
prophylactic effect of a candida mouthwash, containing the curolox™ peptide

Conditions: Erosion of Teeth, Unspecified

Summary: in vitro results showed a protective effect against acids for the mouthwash containing curolox™ peptide. the goal of this in situ study is to detect the curolox™ peptide under natural oral conditions on the tooth surface and to proof the in vitro results obtained. so far there are no effect and safety data of the curolox™ mouthwash under natural oral conditions available.

the primary objective of the study is the detection of the curolox™ peptide on the bovine enamel sample (proof-of-concept) under in vivo conditions after rinsing with the peptide-containing mouth wash. secondary objectives the secondary objectives of the study are: 1. safety and tolerance of the mouthwash in participants 2. identification of the duration the curolox™ peptide is present on the bovine tooth surface under in vivo conditions 3. identification of the most effective mouthwash rinsing volume (2.5 ml or 5 ml) 4. prophylactic effect of multiple applications of the mouthwash confirmation of the prophylactic effect of the curolox™ peptide obtained in in vitro study

Eligibility criteria:
inclusion criteria: * willing and able to understand and to follow the study procedures and instructions * willing to wear a dental appliance for 7 days * willing and able to attend the on-study visits * good oral hygiene throughout the study * written informed consent before participation in the study exclusion criteria: * volunteer with an active periodontal disease or periodontal surgery \< 1 year prior to study participation * volunteer with hypersensitive teeth or with any other (painful) oral pathology or defect * volunteer with an orthodontic appliance * volunteer undergoing a medical treatment * volunteer who is allergic to dental products * pregnant and lactating woman * concurrent participation in another clinical trial
value of urine strem-1 on early predicting aki in sepsis

Conditions: Acute Kidney Injury; Sepsis

Summary: the purpose of this study is to determine the value of urine strem-1 on early predicting secondary acute kidney injury in sepsis

the clinical trial is a prospective, controlled study. all subjects were selected from among inpatients who were hospitalized between sep.2016 and dec.2018 in the respiratory icu, surgical icu and emergency icu of 6 general hospitals in beijing. based on the sepsis 3.0,the population(500 subjects) selected met the diagnostic criteria. based on the kdigo (nephrol dial transplant. 2012) defines aki as 3 degrees, the subjects were divided into acute renal injury group (aki group) and non-acute renal injury group (non-aki group). approximately 110 healthy volunteers enrolled as control group. urine samples were collected from day 1 to day 28 in all patient groups (or to the terminal time point of death), serum samples were collected on days 1, 3, 5, 7, 10, and 14 and the samples were collected from healthy subjects on the day of enrollment. blood was centrifuged at 3,000 rpm for 15 minutes, and urine at 2,000 rpm for 5 minutes. the supernatants were transferred to eppendorf tubes and stored at -80°c. all the specimens were re-numbered before the experiment. urine strem-1 was measured by a double antibody sandwich elisa. this study was approved by the ethics committee of the cpla general hospital (project no.2014-113-02). the following clinical datas were recorded for all patients through the unified database software: (1) basic clinical information: hospital number, gender, age, underlying disease, hospital admission. (2) daily vital signs after admission: body temperature, blood pressure, heart rate, respiratory rate, 24h urine volume, glasgow score. (3) apache ii score and sofa score: arterial blood gas analysis, blood routine, c-reactive protein, procalcitonin, blood biochemistry (liver function, renal function, brain natriuretic peptide, blood electrolytes) the apache ii score and the sofa score were calculated. (4) 28-day outcome (survival or death). statistical analyses were conducted by spss 16.0 (spss, chicago,il, usa) and a two-tailed p \< 0.05 was considered significant.

Eligibility criteria:
inclusion criteria: all subjects meet the standards of sepsis 3.0 diagnostic criteria for the diagnosis of sepsis. exclusion criteria: the following situations can not occur when all subjects are enrolled 1. age\> 80 years or \<18 years 2. chronic renal insufficiency, renal transplantation 3. blood purification treatment 4. aki has occurred
intravesical ty21a for the treatment of patients with non-muscle-invasive bladder cancer (nmibc)

Conditions: Non Muscle Invasive Bladder Cancer

Summary: bladder cancer is the fourth and eighth most common malignancy among men and women, respectively. about 75% of bladder cancers are diagnosed as non muscle-invasive and according to specific tumor-stage and grade characteristics, intravesical immunotherapy with bacillus calmette-guérin (bcg) is used to prevent recurrence and/or progression. however, bcg immunotherapy is associated with significant adverse events and treatment failure may occur in 30-40% of cases, hence the necessity for alternative therapies. in an orthotopic mb49 mouse bladder cancer model, another bacterial vaccine (ty21a/vivotif) turned out to be more effective than bcg for inducing tumor regression and mice survival upon intravesical instillation; and potentially safer because ty21a bacteria did not infect/persist in any mice tissues nor in human bladder explants or cell lines, in contrast to bcg. ty21a/vivotif has been used in the last 30 years in millions of individuals as an oral typhoid vaccine with a high safety record. in this phase i trial we will be testing the safety of intravesical administration of ty21a and its effect on bladder immunity in non-muscle invasive bladder cancer (nmibc) patients, for whom recommendation of bcg therapy is not mandatory.

escalating doses of ty21a/vivotif® will be administered by the intravesical route to evaluate whether ty21 may replace the standard bcg immunotherapy in nmibc patients. the minimal starting dose will be instilled intravesically once a week for 4 weeks in 3 patients. if well tolerated, a 5-fold higher dose will be instilled 4-times in 3 other patients, and so on for a maximum of 4 doses to be tested. the maximal tolerated dose will then be administered to 3 new patients 6-times once a week. if 6 instillations are well tolerated, 7 additional patients will be included to receive 6 instillations with this maximal tolerated dose.

Eligibility criteria:
inclusion criteria: * patients with an intermediary or low risk of progression of bladder cancer (according to an eortc score and clinical considerations) and thus not requiring bcg immunotherapy will be included after a transurethral resection of the bladder tumor (turbt). male and female patients aged \> 18yrs, with a karnofsky performance status of 60% or more, sero-negative for hiv, hbv and hcv and with laboratory parameters for vital function in the normal range or with abnormalities without clinical significance may be included. exclusion criteria: * patients with nmibc that require bcg treatments or with muscle-invasive bladder cancer, sero-positive for hiv, hbv and hcv or with other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders, autoimmune disease), will be excluded.
sensitivity of fecal immunochemical test (fit) for colorectal cancer (crc) screening

Conditions: Colorectal Neoplasms Malignant; Colonoscopy; Early Detection of Cancer; Female; Mass Screening; Middle Aged; Occult Blood

Summary: fecal immunochemical test (fit) was introduced in france late 2015, fit has better diagnostic accuracy for colorectal cancers (crcs) than previous screening tests. our primary objective was to evaluate the sensitivity of fit and the proportion of interval cancer.

fecal immunochemical test (fit) aims to detect pre-symptomatic lesions, i.e., early stage colorectal cancers (crcs) or pre-cancerous lesions such as colonic adenomas in order to reduce crc mortality. fit was introduced in france late 2015, fit has better diagnostic accuracy for crcs than previous screening tests. determining the incidence of post-test interval crcs, diagnosed after a negative fit and before the recommended date of the next test (2-year interval), allows assessment of the sensitivity of the test. the primary objective of this study was to evaluate the performance of fit during the crc screening campaign in the finistère department (france) from january 1, 2016 to december 31, 2017. its secondary objectives were the evaluation of diagnostic circumstances and their impact on treatment and survival, and risk factors for interval cancer (ic).

Eligibility criteria:
inclusion criteria: * all subjects between 50 and 77 years diagnosed with an in situ or an invasive crc * inhabitants of the finistère area * subjects were included by period: * from january 2016 to december 2017 for subjects with sd-crc, non-responders and the excluded population * from january 2016 to december 2019 for subjects with fit-ics (2-year interval) * from january 2016 to december 2020 for subjects with post-colonoscopy ic * from january 2018 to december 2020 for subjects with delayed diagnosis exclusion criteria: * subjects who refused to participate in the case of refusal of data collection * subject swith crc other than adenocarcinoma were excluded.

Keywords: screening fecal immunochemical test survival interval cancer
a sunscreen based on bioadhesive nanoparticles

Conditions: Melanoma; UV Ray Skin Damage

Summary: the initial focus of the study will be on safety, sun protection factor (spf) characterization, and substantivity (duration of protection) studies. the primary outcome of the study will be to measure the sun protection factor (spf) of a bioadhesive nanoparticles (bnp) formulation in 20-25 healthy volunteers with fair skin.

the purpose of this study will be to evaluate the duration of protection and efficacy of a novel bioadhesive nanoparticle sunscreen in 20-25 human volunteers.this technology makes sunscreens safer and longer-lasting by encapsulating uv sunscreen active agents in non-toxic nanoparticles. strong preclinical data exists demonstrating the potential for improved safety, long-duration of retention, and increased effectiveness of this product. this innovative solution focuses on preventing damage caused by uv exposure through the use of a nanoparticle delivery vehicle. the bioadhesive feature of this technology enables longer protection. in addition, encapsulation of the uv filter in a bioadhesive nanoparticle (bnp) improves filter photo-stability, delays filter photo-degradation, and prevents reactive oxygen species (ros) escape, thereby reducing the risk of cell damage and epidermal toxicity from uv filters. furthermore, the bioadhesive feature of our technology eliminates penetration into deeper skin layers or into the blood, minimizing the potential side-effects of uv filters. it is believed that the translation of this technology will provide a longer-lasting, safer, more protective uv sunscreen.

Eligibility criteria:
inclusion criteria: * subjects must be in good health with minimal skin irregularities, as evaluated by a physical examination. * the physical examination shall determine the presence of sunburn, suntan, scars, active dermal lesions, and uneven skin tones on the areas of the back to be tested. the presence of nevi, blemishes, or moles will be acceptable if in the physician's judgment they will not interfere with the study results. excess hair on the back is acceptable if the hair is clipped or shaved. * subjects must fall into one of the following 3 fitzpatrick skin scale categories: 1. always burns easily; never tans (sensitive) 2. always burns easily; tans minimally (sensitive) 3. burns moderately; tans gradually (light brown) (normal) exclusion criteria: * volunteers cannot have a history of skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or melanoma). * volunteers cannot have a history of skin disease (such as psoriasis, exema, or vitiligo).

Keywords: sunscreen melanoma improved protection from uv rays
the effects of music therapy as a complementary intervention in the treatment of pediatric asthma

Conditions: Asthma

Summary: the onset of asthma is particularly frightening for children. when the symptoms of asthma decrease, children and parents forget about the maintenance and control of breath and lung volume. because adherence is so poor, asthma is known as the emergency room illness. the playing of a wind instrument is a unique way to provide a creative means for children and teens to understand both the impact of diaphramatic breathing and their ability to control it as well. this study builds upon the evidence, though sparse, that suggest that the blowing of a wind instrument with clinical music therapy intervention strengthens the muscles of breathing and fortifies the incentive toward attending to the daily symptoms and general management of asthma.


Eligibility criteria:
inclusion criteria: * between the ages of 7 and 18 * diagnosed with asthma exclusion criteria: * over 18
aprove : irbesartan in hypertension

Conditions: Hypertension

Summary: study objective : to compare efficacy and tolerability of posology adaptation of irbesartan in ambulatory hypertensive patients


Eligibility criteria:
inclusion criteria: * patient with mild or moderate hypertension defined with arterial diastolic pressure (pad) at sit position between 90 mmhg and 110 mmhg and arterial systolic pressure (pas) at sit position between 140 mmhg and 180 mmhg. * patient diagnosed after 3 consultations within 2 months who has never been under treatment and responding to the required conditions for hypertension treatment with irbesartan. this patient must has been under proper but insufficient hygieno dietetic diet * patient who has been under a none satisfied antihypertensive treatment, and for whom this treatment was stopped at least 2 weeks prior to inclusion. * patient with a laboratory analysis (urinary sediment- na -k- creatinine, total cholesterol) and ecg during the month prior to inclusion. exclusion criteria: * severe hypertension defined by pas \> 180mmhg and/or pad \> 110 mmhg. * isolated systolic hypertension * secondary hypertension * arterial stenosis on unique kidney - arterial bilateral kidney stenosis * non-surgically sterilized women or non-menopaused women. * confirmed sodic depletion. * hypersensitivity to irbesartan. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
identification of biomarkers in the legal medical skin wounds

Conditions: Legal Medical Skin Wounds

Summary: identify the cytokine or combination of cytokines, with the best diagnostic performance to characterize the vital nature of a skin wound in the body.

determining the vitality of skin wounds, that is to say their antemortem character, is an important issue in forensic pathology. the only criterion vitality currently recognized (but whose diagnostic performance remains limited) is the microscopic demonstration of an inflammatory infiltrate of neutrophils. the search for more reliable diagnostic biomarkers is required. by their early expression of the injury site, inflammatory cytokines are potential candidates and their quantification in injured skin could optimize the diagnosis of vitality injury. the objective is to identify the cytokine or combination of cytokines, with the best diagnostic performance to characterize the vital nature of a skin wound in the body.

Eligibility criteria:
inclusion criteria: * adult died 18 years or more * having at least one recent ante-mortem skin wound (occurring less than 4 hours prior to death) * hours of death and the establishment of the ante-mortem wound known (date, hours and minutes) exclusion criteria: * immunocompromised patients (hiv infection, immunosuppressive therapy ...) * putrefaction signs (abdominal patch of green ...)
of sodium glucose cotransporter-2 inhibitors on metabolic, hormonal and clinical parameters in pco

Conditions: PCO

Summary: the aim of this study is to compare the hormonal, metabolic and clinical effects of metformin and dapagliflozin as monotherapies and the effect of both of them as a combined therapy in infertile women with pcos.

it is a prospective randomized controlled trial .the study will include 200 randomly selected infertile women aged between 18 and 45 years, from gynecology and obstetrics department beni-suef university hospital whom diagnosed with polycystic ovarian syndrome (pcos), according to rotterdam criteria (bmi≥ 24kg/m, homeostatic model assessment of insulin resistance (homa-ir with cutoff ≥ 2.5 biochemical hyperandrogenism, as indicated by a free androgen index (fai) \>4, and self-reported oligomenorrhea (cycle length \>35 days and 9 or fewer periods per year) or amenorrhoea (absence of menses for a period ≥3 months) will be included for the study. i the study will include four groups; each group consists of 50 patients:- * group i (n=50) will be treated by metformin monotherapy. * group ii (n=50) will be treated by dapagliflozin monotherapy . * group iii (n=50) will be treated by metformin and dapagliflozin combined therapy * group iv (n=50) will be a control group.

Eligibility criteria:
inclusion criteria: * women are aged between 18 and 45 years * no pregnancy plan within the next 6 months * polycystic ovarian syndrome (pcos), according to rotterdam criteria exclusion criteria: 1. congenital adrenal hyperplasia 2. poorly controlled thyroid disease 3. taking antidiabetic drugs which can affect insulin resistance 4. chronic kidney disease and history of recurrent urinary tract infections 5. liver dysfunction (ast or alt \> 3 times the upper limit of normal or gfr\<30 ml/min/1.73m2) 6. documented use of oral hormonal contraceptives and hormone-releasing implants